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NCT03926767

Additional Effect of Pain Neuroscience Education to Orofacial and Neck Exercises in Temporomandibular Disorders

Completed NA Last updated 1 December 2023
What this trial tests

NA trial testing Pain Neuroscience Education (PNE) in Temporomandibular Disorders in 148 participants. Completed in 28 February 2022.

Timeline
10 May 2019
Primary endpoint
30 October 2020
28 February 2022

Quick facts

Lead sponsorUniversity of Sao Paulo
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment148
Start date10 May 2019
Primary completion30 October 2020
Estimated completion28 February 2022
Sites1 location across Brazil

Drugs / interventions tested

Conditions studied

Sponsor

University of Sao Paulo

Who can join

Adults 18 to 55, any sex, with Temporomandibular Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The objective of this study will be to verify the additional effect of Pain Neuroscience Education program to orofacial manual therapy and orofacial and neck motor control exercises for pain intensity and disability and for the secondary outcomes pain self-efficacy, kinesiophobia, and overall perception of improvement in patients with Temporomandibular Disorders (TMD). This study will be a randomized clinical trial comprising a sample of 148 participants. Subjects will undergo a screening process to verify those presenting a diagnosis of painful TMD confirmed by the Research Diagnostic Criteria (RDC/TMD), between 18 and 55 years of both genders, and then the volunteers will be randomized into two groups (G1: Pain Neuroscience Education + Orofacial Manual Therapy/orofacial exercises/neck motor control exercises vs. G2: Orofacial Manual Therapy/orofacial exercises/neck motor control exercises). These volunteers will be recruited at the Dentistry Clinic of the University of São Paulo's School of Dentistry of Ribeirão Preto - University of São Paulo. The intervention will be administered twice a week for 6 weeks by a single therapist lasting 1 hour per session. The primary outcome will be pain intensity and disability and the secondary outcomes will be pain self-efficacy, kinesiophobia and overall perception of improvement. The participants will be assessed immediate after the last session and at one and three-month follow-ups.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Education-Enhanced Conventional Care versus Conventional Care Alone for Temporomandibular Disorders: A Randomized Controlled Trial.
    Aguiar ADS, Moseley GL, Bataglion C, Azevedo B, et al · · 2023 · cited 16× · PMID 36220481 · DOI 10.1016/j.jpain.2022.09.012
  2. Additional effect of pain neuroscience education to craniocervical manual therapy and exercises for pain intensity and disability in temporomandibular disorders: a study protocol for a randomized controlled trial.
    Dos Santos Aguiar A, Bataglion C, Felício LR, Azevedo B, et al · · 2021 · cited 5× · PMID 34488856 · DOI 10.1186/s13063-021-05532-x

Verify or expand the search:

Other trials of Pain Neuroscience Education (PNE)

Trials testing the same drug.

Other recruiting trials for Temporomandibular Disorders

Currently open trials in the same condition.

Other University of Sao Paulo trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing